A Study of AA4500 in Men With Peyronie's Disease

NCT ID: NCT01243411

Last Updated: 2017-10-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 348 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2012-08-31

Brief Summary

This study is a Phase 3, open-label study of the safety and efficacy of AA4500 0.58 mg in subjects with Peyronie's disease. Subjects will be screened for study eligibility within 21 days before the initial injection of study drug in the first treatment cycle.

After up to four treatment cycles, each subject will be followed for additional safety and efficacy assessments on Days 168 (± 7 days) and 252 (± 7 days) (nominal weeks 24 and 36).

After the final injection of each treatment cycle, the investigator will model the plaque in an attempt to stretch or elongate the plaque. If the subject's penile curvature is reduced to <15° after the first, second, or third cycle of injections or if the investigator determines further treatment is not clinically indicated (eg, adverse events; allergic reaction), subsequent treatment cycles will not be administered.

Approximately 300 subjects will be enrolled.

Conditions

Peyronie's Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AA4500

collagenase clostridium histolyticum

Group Type: EXPERIMENTAL

AA4500

Intervention Type: BIOLOGICAL

2 injections separated by at least 24 hours but not more than 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles (ie, total of up to 8 injections per subject)

Interventions

AA4500

2 injections separated by at least 24 hours but not more than 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles (ie, total of up to 8 injections per subject)

Intervention Type: BIOLOGICAL

Other Intervention Names

XIAFLEX

Eligibility Criteria

Inclusion Criteria

No subject should be enrolled until all eligibility criteria have been satisfied. Subjects who receive placebo in a previous Auxilium-sponsored study may enroll in this study provided they continue to meet the eligibility requirements. To qualify for the study a subject must:

1. Be a male and be ≥ 18 years of age

2. Be in a stable relationship with a female partner/spouse for at least 3 months before screening and be willing to have vaginal intercourse with that partner/spouse

3. Have symptom(s) of Peyronie's disease for at least 12 months before the first dose of study drug and have evidence of stable disease as determined by the investigator

4. Have penile curvature of at least 30° in the dorsal, lateral, or dorsal/lateral plane at screening. It must be possible to delineate the single plane of maximal curvature for evaluation during the study

5. Be judged to be in good health, based upon the results of a medical history, physical examination, and laboratory profile

6. Voluntarily sign and date an informed consent agreement approved by the Institutional Review Board/Independent Ethics Committee (IRB/IEC). The subject must also sign an authorization form to allow disclosure of his protected health information (PHI). The PHI authorization form and informed consent form may be an integrated form or may be separate forms depending on the institution

7. Be able to read, complete and understand the various rating instruments in English or the appropriate local language for the country in which the study is being performed.

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Exclusion Criteria

A subject will be excluded from study participation if he:

1. Has a penile curvature of less than 30° or greater than 90° at the screening visit

2. Has any of the following conditions:

• Chordee in the presence or absence of hypospadias
• Thrombosis of the dorsal penile artery and/or vein
• Infiltration by a benign or malignant mass resulting in penile curvature
• Infiltration by an infectious agent, such as lymphogranuloma venereum
• Ventral curvature from any cause
• Presence of an active sexually transmitted disease
• Known active hepatitis B or C
• Known immune deficiency disease or be positive for human immunodeficiency virus (HIV)

3. Has previously undergone surgery for Peyronie's disease

4. Fails to have an erection which in the opinion of the investigator is sufficient to accurately measure the subject's penile deformity after administration of prostaglandin E1 or trimix

5. Has a calcified plaque as evident by appropriate radiographic evaluation, penile x-ray or penile ultrasound that would prevent proper injection of study medication (penile ultrasound only in EU countries). Non-contiguous stippling of calcium is acceptable for inclusion provided the calcium deposit does not interfere with the injection of AA4500 into the plaque

6. Has an isolated hourglass deformity of the penis

7. Has the plaque causing curvature of the penis located proximal to the base of the penis, so that the injection of the local anesthetic would interfere with the injection of AA4500 into the plaque

8. Has previously received alternative medical therapies for Peyronie's disease administered by the intralesional route (including, but not limited to, steroids, verapamil, and the naturally occurring low molecular weight protein, interferon-α2b) within 3 months before the first dose of study drug or plans to use any of these medical therapies at any time during the study

9. Has received alternative medical therapies for Peyronie's disease administered by the oral (including, but not limited to, vitamin E [> 500 U], potassium aminobenzoate [Potaba], tamoxifen, colchicine, pentoxifylline, over-the-counter erectile dysfunction medications, or steroidal anti-inflammatory drugs) or topical routes (including, but not limited to, verapamil applied as a cream) within 3 months before the first dose of study drug or plans to use any of these medical therapies at any time during the study

10. Has had extracorporeal shock wave therapy (ESWT) for the correction of Peyronie's disease within the 6-month period before screening or plans to have ESWT at any time during the study

11. Has used any mechanical type device for correction of Peyronie's disease within the 2-week period before screening or plans to use any these devices at any time during the study

12. Has used a mechanical device to induce a passive erection within the 2-week period before screening or plans to use any of these devices at any time during the study

13. Has significant erectile dysfunction that has failed to respond to oral treatment with phosphodiesterase type 5 (PDE5) inhibitors

14. Has a penile Duplex Doppler ultrasound evaluation at screening that shows compromised penile hemodynamics that in the opinion of the investigator is clinically significant

15. Has uncontrolled hypertension, as determined by the investigator

16. Has a known recent history of stroke, bleeding, or other significant medical condition, which in the investigator's opinion would make the subject unsuitable for enrollment in the study

17. Is unwilling or unable to cooperate with the requirements of the study including completion of all scheduled study visits

18. Has received an investigational drug or treatment within 30 days before the first dose of study drug, except for subjects who receive one treatment cycle of AA4500 in Study AUX-CC-805

19. Has a known systemic allergy to collagenase or any other excipient of AA4500

20. Has a known allergy to any concomitant medication required as per the protocol

21. Has received anticoagulant medication (except for ≤ 165 mg aspirin daily or ≤ 800 mg of over-the-counter NSAIDS daily) during the 7 days before each dose of study drug

22. Has received any collagenase treatments within 30 days of the first dose of study drug, except for subjects who receive one treatment cycle of AA4500 in Study AUX-CC-805

23. Has, at any time, received AA4500 for the treatment of Peyronie's disease, except for subjects who receive one treatment cycle of AA4500 in Study AUX-CC-805

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Endo Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gregory J. Kaufman, MD

Role: STUDY_DIRECTOR

Auxilium Pharmaceuticals, Inc.

Locations

Urology Associates Medical Group

Burbank, California, United States

Connecticut Clinical Research Center, LLC

Middlebury, Connecticut, United States

The Urology Center, P.C.

New Haven, Connecticut, United States

South Florida Medical Research

Aventura, Florida, United States

Urology Specialists, S.C.

Chicago, Illinois, United States

Northeast Indiana Research, LLC

Fort Wayne, Indiana, United States

Metropolitan Urology, P.S.C.

Jeffersonville, Indiana, United States

Maimonides Medical Center, Division of Urology

Brooklyn, New York, United States

University Urology Associates

New York, New York, United States

Tristate Urologic Services PSC, Inc./ dba TUG Research

Cincinnati, Ohio, United States

Urologic Consultants of SE PA

Bala-Cynwyd, Pennsylvania, United States

Urology of Virginia-Sentara Medical Group

Norfolk, Virginia, United States

Virginia Urology

Richmond, Virginia, United States

Aarhus Universitiy Hospital, Aalborg Sygehus

Aalborg, , Denmark

Frederiksberg Hospital

Frederiksberg, , Denmark

Frederikssunds Hospital

Frederikssund, , Denmark

Klinik for seksuelle dysfunktioner

Gentofte Municipality, , Denmark

Centre Hospitalier Edouar Herriot

Lyon, , France

Hopital Henri Gabrielle

Saint-Genis-Laval, , France

Universitatsklinikum Freiburg, Abteilung Urologie

Freiburg im Breisgau, , Germany

Private Practice of Urology/Andrology

Hamburg, , Germany

Uro-Onkologische Praxis Dr. von Keitz

Marburg, , Germany

Urologische Gemeinschaftspraxis Reutlingen

Reutlingen, , Germany

Universitatsklinikum Tubingen

Tübingen, , Germany

University of Naples "Federico II"

Naples, , Italy

Universitiy Tor Vergatat of Rome

Rome, , Italy

Waitemata Urology Research North Shore Hospital

Takapuna, Auckland, New Zealand

Tauranga Urology Research Ltd.

Tauranga, Bay of Plenty, New Zealand

Primorus Clinical Trials Ltd.

Christchurch, Canterbury, New Zealand

CURT Medical Trials Trust Board Inc.

Christchurch, Canterbury, New Zealand

Cardinal Points Research Ltd.

Whangarei, Northland, New Zealand

Wellington Urology Associates

Wellington South, Wellington Region, New Zealand

Hospital Clinic de Barcelona

Barcelona, , Spain

Hospital La Zarzuela

Madrid, , Spain

Specialistmottagningen i urologi

Gothenburg, , Sweden

Carlshamns Specialistklinik

Karlshamn, , Sweden

Akademiska Sjukhuse

Uppsala, , Sweden

St. Peter's Andrology Centre

London, , United Kingdom

Sunderland Royal Hospital

Sunderland, , United Kingdom

Countries

United States; Denmark; France; Germany; Italy; New Zealand; Spain; Sweden; United Kingdom

References

Levine LA, Cuzin B, Mark S, Gelbard MK, Jones NA, Liu G, Kaufman GJ, Tursi JP, Ralph DJ. Clinical safety and effectiveness of collagenase clostridium histolyticum injection in patients with Peyronie's disease: a phase 3 open-label study. J Sex Med. 2015 Jan;12(1):248-58. doi: 10.1111/jsm.12731. Epub 2014 Nov 12.

Reference Type: DERIVED

PMID: 25388099 (View on PubMed)

Other Identifiers

AUX-CC-802

Identifier Type: -

Identifier Source: org_study_id